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Recruiting NCT05397717

Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

Observational Pneumothorax, Spontaneous

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational.
Who it may be relevant to
Registry conditions: Pneumothorax, Spontaneous. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.

Detailed description

Pneumothorax is a common respiratory disease and potentially recurrent, especially among patients with pre-existing lung diseases. It frequently requires in-patient care due to the need for invasive therapeutic procedures.

Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. The in-hospital mortality rate of spontaneous pneumothorax ranges between 0.7% and 15%, which is dependent on age, mode of admission and presence of co-existing lung diseases. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. A multicentre retrospective study in Hong Kong evaluating patients admitted for pneumothorax in the year 2004 reported a mortality rate of 0.6% in those who had failed drainage with intercostal tube drainage. However, this study was not powered to investigate the overall mortality rate of pneumothorax and its predictive factor.

The majority of patients with pneumothorax can be discharged after the resolution of pneumothorax. However, a significant proportion of them may experience prolonged stay in the hospital due to various complications secondary to pneumothorax, including subcutaneous emphysema, persistent air leakage, and hospital-acquired pneumonia. All these conditions may cast negative impact on the overall prognosis, burden of pleural intervention and length of stay. Again, the incidence rate and determining factors of these conditions are seldomly reported.

This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.

Interventions

  • Other observational
    Observational, without interfering the patient care of treating doctors

Primary outcome measures

  • To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital [Time frame: 36 months]
Secondary outcome measures (3)
  • To evaluate clinical characteristics and causes of pneumothorax [Time frame: 36 months]
  • To evaluate the risk factors and causes for in-hospital mortality of spontaneous pneumothorax [Time frame: 36 months]
  • To evaluate other short and long-term outcomes due to pneumothorax [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • All patients with a confirmed diagnosis of spontaneous pneumothorax on admission or during the hospital stay
  • Age greater than 18 years old
  • Chinese ethnicity
  • Able to sign written informed consent to participate in the study

Exclusion criteria

  • Pneumothorax was not found by thoracic imaging
  • Traumatic pneumothorax (including iatrogenic pneumothorax)
  • Pneumothorax with recent (within one month) lung resection surgery, that may be due to staple line issues
  • Trapped lung or non-expandable lungs, without evidence of air leakage
  • Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT05397717 · PTX_outcomes_prospective

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗